The present invention pertains to a myringotomy tube inserter. More specifically, the present invention pertains to a myringotomy tube inserter particularly suited for use in inserting such tubes in incisions made in the tympanic membrane of the ear, including twisting of the tube to achieve full insertion.
The insertion of myringotomy drainage tubes in the tympanic membrane of the ear is a common operation which is well known in the art. The operation generally includes the steps of (1) first producing an incision in the tympanic membrane by use of a scalpel or other perforating instrument, (2) inserting a suction needle through the incision and into the middle ear to withdraw fluids therefrom, and (3) inserting a myringotomy tube into the incision.
Several means have been provided in the prior art for the insertion of myringotomy tubes in the incision of the tympanic membrane. It is not uncommon for these devices to include a shaft and a sleeve for the shaft, such that a myringotomy tube can be placed on an end of the shaft. After the tube is inserted in the incision of the ear drum, the myringotomy tube can be released from the end of the shaft by retracting the shaft into the sleeve. These devices of the prior art have met with some success for the insertion of certain types of tubes but, because no provision has been made in the prior art for the deliberate rotation of the shaft within the sleeve, the insertion devices of the prior art have met with only limited success in the insertion of other types of myringotomy tubes.
Myringotomy tubes are available in a wide variety of shapes. The essential characteristic of these tubes is that they are able to prevent the closing of the incision in the ear drum while presenting a hole through the center of the tube through which fluids can drain from the middle ear. Myringotomy tubes can be composed of many different types of materials, an example of which is a soft, pliable silicon rubber composition.
The insertion of certain types of myringotomy tubes is facilitated by a twisting action during the insertion step. As an example of such types of tubes, the description of the tube in U.S. Pat. No. 3,807,409, issued to Paparella et al is hereby incorporated by reference. The tube of U.S. Pat. No. 3,807,409 is constructed in a tubular shape having an inner and an outer flange, the inner flange being substantially larger than the outer flange. The inner flange is also characterized by a V-shaped notch which assists in the insertion of the tube. To insert the tube in the incision made in the tympanic membrane, the tube is first partly inserted into the incision and then simply twisted until the remainder of the inner flange threads itself entirely below the surface of the tympanic membrane. Myringotomy tube inserters of the prior art are unable to provide such a twisting action, since they do not provide means for the deliberate rotation of the shaft.
Thus, there exists a need in the art for a myringotomy tube inserter which enables a twisting action to facilitate the insertion of myringotomy tubes. Advantageously, the inserter will also be disposable and durable, and will allow the surgeon to observe the point of insertion without having his vision blocked by the inserting device.